Monoclonal Gammopathy of Renal Significance (MGRS)
Conditions
Keywords
PGNMIDs, LCPT, TMA, CGGN, daratumumab
Brief summary
This is an open-label, multicenter, phase 2 study in subjects with newly diagnosed proliferative glomerulonephritis with monoclonal immunoglobulin deposits (PGNMIDs), OR light chain proximal tubulopathy (LCPT), OR thrombotic Microangiopathy (TMA), OR cryoglobulinemic glomerulonephritis, (CGGN), treated with daratumumab, bortezomib, cyclophosphamide, and dexamethasone.
Detailed description
The current study aims to investigate daratumumab, bortezomib, cyclophosphamide, and dexamethasone regimen in patients with newly diagnosed PGNMIDs, LCPT, TMA, CGGN. Approximately 10 subjects will receive primary therapy with daratumumab-CyBorD. The primary endpoint is overall complete hematologic response (CHR) rate at 6 months.
Interventions
DRUGDara-CyBorD
Dara-CyBorD will be used for newly diagnosed PGNMID, OR LCPT, OR TMA OR CGGN.
Sponsors
Peking University People's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of PGNMIDs, OR LCPT, OR TMA, OR CGGN. 2. Evidence of clonal plasma cell in bone marrow. 3. ECOG 0,1,2 4. Neu≥ 1.0\*10\^9/L, HGB ≥70g/L, PLT ≥ 50\*10\^9/L. 5. Total bilirubin (TBil) ≤3×upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN; 6. Informed consent explained to, understood by and signed by the patient.
Exclusion criteria
1. Prior therapy for MGRS, with the exception of equal or less than 160 mg dexamethasone (or equivalent corticosteroid) 2. Fulfill with the criteria of active multiple myeloma or active lymphoplasmacytic lymphoma. 3. Presence of other tumors which is/are in advanced malignant stage and has/have systemic metastasis; 4. Severe or persistent infection that cannot be effectively controlled; 5. Presence of severe autoimmune diseases or immunodeficiency disease; 6. Patients with active hepatitis B or hepatitis C (\[HBVDNA+\] or \[HCVRNA+\]); Patients with HIV infection or syphilis infection; 7. Any situations that the researchers believe will increase the risks for the subject or affect the results of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hematologic Complete Response at the completion of 6 cycles | 6 months | Hematologic complete response requires absence of monoclonal protein by immunofixation electrophoreses of both serum and urine as well as a normal FLC ratio (FLCr). CR is considered when FLCr was altered in favour of the non-amyloidogenic, uninvolved FLC (uFLC), even though the ratio may not have been normalised. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Hematologic ORR (Overall Response, CR+VGPR+low-dFLC response+PR) at the completion of 6 cyels | 6 months | — |
| Renal response at 6 months | 6 months | — |
| MRD status at 6 months | 6 months | — |
| Rate of Hematologic CR (Complete Response)+ VGPR (very good partial response) at the completion of 6 cyels | 6 months | — |
| Overall Survival in 2 years | 2 years | — |
| TRAEs | 2 years | Treatment-related adverse events up to 2 years |
| Renal Survival in 2 years | 2 years | — |
Contacts
Primary ContactYang Liu
Outcome results
None listed